E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Autism spectrum disorders |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Mental Disorders [F03] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective is to identify effects of 24 IU oxytocin delivered intranasally twice-daily for four weeks on measures of social and repetitive behaviors compared to placebo in youth diagnosed with ASD. |
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E.2.2 | Secondary objectives of the trial |
• To identify effects of 24 IU oxytocin delivered intranasally twice-daily for four weeks on behavioral inflexibility in ASD patients • To identify effects of 24 IU oxytocin delivered intranasally twice-daily for four weeks on performance in lab-based cognitive tasks in ASD patients • Document safety (adverse event profile) of 24 IU oxytocin delivered intranasally twice-daily for four weeks in ASD patients
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male and female participants between the ages of 12 and 20, both inclusive, with a confirmed diagnosis of autism spectrum disorder (ASD) diagnosis 2. Participants must be in good general physical health, as determined by the investigator. 3. Participant’s pre-study physical examination and vital signs must not show any clinically significant abnormalities as determined by the investigator. 4. Participants and caregivers must be able to communicate well with the investigator, to understand and comply with the requirements of the study, and to understand the oral and written study information
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E.4 | Principal exclusion criteria |
1. Participants with a clinically relevant history of significant hepatic, renal, endocrine, cardiac, nervous, pulmonary, haematological or metabolic disorder. 2. Somatic illness requiring treatment within 2 weeks prior to Study Day 1. 3. Full scale IQ < 70 (due to the prerequisite ability to complete self-report measures). 4. Known allergic reactions or hypersensitivity to any component of the study medication in the nasal spray, such as propyl parahydroxybenzoate (E216), methyl parahydroxybenzoate (E218) and chlorobutanol hemihydrate. 5. Pregnancy (self-reported or assessed by pregnancy test prior to the first administration at Experimental session 1 and 2 for all menstruating females) 6. Participation in any other clinical trial with an investigational medicinal product or medical device within 3 months prior to randomisation. 7. Other unspecified reasons that, in the opinion of the investigator or the sponsor make the participant unsuitable for enrollment
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoints are measures of social and repetitive behavior: o Social behavior after four weeks of treatment assessed with the total score of the Social Responsiveness Scale-Second Edition (SRS-2), completed by caregivers of the participants o Repetitive behaviour after four weeks of treatment assessed with the Repetitive Behavior Scale-Revised (RBS-R), completed by caregivers of the participants
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
o Behavioral inflexibility after four weeks of treatment assessed with the Behavioral Inhibition scale (BIS), completed by caregivers of the participants o Social cognition assessed by a computerized Emotional body language task, completed by the participants o Repetitive cognition will be assessed by a probabilistic reversal task, completed by research participant o Heart rate variability, measured using electrocardiogram (ECG)
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |